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NCT Number: NCT05888246

Measuring the Range of Cardiac Magnetic Parameters in Healthy Subjects by Magnetocardiogram

A prospective and observational clinical study of measuring the range of cardiac magnetic parameters in healthy people with the magnetocardiogram manufactured by Hangzhou Nuochi Life Science Co., LTD

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Key information

Conditions

Healthy People

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

About this study

This study is a prospective and observational study on the collection of cardiac magnetic signals from healthy subjects by magnetocardiogram. It is expected that 412 subjects will be examined by magnetocardiography, and the range of parameters related to magnetocardiography in healthy subjects will be reported.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy people aged 18-70 years old;
  • Subjects receiving physical examination in physical examination institutions, or in other departments other than heart disease (such as orthopedics, gynecology, etc.), or in cardiology department, excluded from coronary heart disease;
  • No history of coronary heart disease;
  • ECG did not indicate myocardial ischemia or infarction;
  • Sinus rhythm without arrhythmia;
  • The subject or the subject's legal representative has been informed of the nature of the study, understands the purpose of the clinical study, voluntarily participates in the study and signs the informed consent.

Exclusion criteria

  • Acute coronary syndrome requires emergency PCI treatment, and it is estimated that magnetic cardiogram examination will affect the timing of emergency PCI surgery;
  • Subjects with metal implants in the thoracic cavity (including the heart cavity), such as those who have received pacemaker therapy or cardiac resynchronization therapy (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) implantation, or those who have received metal heart valve implantation;
  • There is hemodynamic instability, which is defined as systolic blood pressure < 80mmHg, or cardiogenic shock; Or need vasoactive drug therapy; Intra-aortic balloon counterpulsation may be required; Or other hemodynamic support devices; As syndrome;
  • Severe tachycardia (ventricular rate > 150 beats/min), ventricular flutter, ventricular fibrillation and other malignant arrhythmias;
  • Subjects unable to lie flat (supine position);
  • Subjects with mental illness, unconscious or uncontrollable ability; Or claustrophobic subjects;
  • Other circumstances in which the investigator considers the subject inappropriate for participation in the study

Treatment and study plan

Magnetocardiogram

Diagnostic Test

Magnetocardiogram consists of acquisition and control system (including software) and detection part. Acquisition and control system mainly includes: cabinet, display, host, sensor. The detection part mainly includes: inspection bed, array sensor support frame, magnetic shielding equipment.

Primary outcomes

  1. PR interval

    Time frame: 24 hours

    PR interval is defined as the position from the starting point of P wave to the starting point of QRS wave after the superposition of 36 channels in the magnetocardiogram (butterfly diagram).

  2. QRS interval

    Time frame: 24 hours

    QRS interval is defined as the time (ms) from the beginning of QRS to the end of QRS after the stacking of 36 channels in the magnetocardiogram (butterfly diagram).

  3. QT interval

    Time frame: 24 hours

    QT interval is defined as the time (ms) from the beginning of Q wave to the end of T wave after the stacking of 36 channels in the magnetocardiogram (butterfly diagram).

  4. Corrected QT interval

    Time frame: 24 hours

    The corrected QT interval was defined as the QTC interval (ms) after the stacking of 36 channels in the magnetocardiogram (butterfly diagram). QTc = QT/(RR^0.5), RR is the average RR interval calculated by cardiac magnetic waveform, QT is QT interval.

  5. The magnetic field intensity parameter (R/T ratio)

    Time frame: 24 hours

    The magnetic field intensity parameter (R/T ratio) is defined as the ratio of the maximum magnetic field intensity of the r-wave vertex to the T-wave vertex of the magnetocardiogram calculated based on the isomagnetic map.

  6. Maximum current vector angle (MCV angle)

    Time frame: 24 hours

    The Angle of the maximum current vector was measured at the vertex of QRS and T wave respectively.

  7. Maximum current vector amplitude (MCV amplitude)

    Time frame: 24 hours

    The amplitude of the maximum current vector was measured at the vertex of QRS wave and T wave respectively.

  8. Total current vector angle (TCV angle)

    Time frame: 24 hours

    TCV represents the total current vector, which is the sum of all current vectors of 36 channels in the magnetocardiogram. First calculate the vector sum of the 36 channels, and finally calculate the angles.

  9. Total current vector amplitude (TCV amplitude)

    Time frame: 24 hours

    TCV represents the total current vector, which is the sum of all current vectors of 36 channels in the magnetocardiogram. First calculate the vector sum of the 36 channels, and finally calculate the amplitude.

Sponsors and collaborators

Lead sponsor

Hangzhou Nuochi Life Science Co., Ltd.

Industry

Registry information

Official study title

Measuring the Range of Cardiac Magnetic Parameters in Healthy Subjects by Magnetocardiogram: a Prospective, Observational Clinical Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 5, 2023
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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